Evaluation of the Effects of Simulation Based Breastfeeding Training

Breastfeeding Clinical Trial

Official title:

Evaluation of the Effects of Simulation Based Breastfeeding Training on Women' Breastfeeding Success, Breastfeeding Self Efficacy, Breastfeeding Attitude and Knowledge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340842
• Other study ID #: 16214662/050.01.04/30
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.

Description:

This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding. The research was carried out with the participation of two groups. In this context, applied breastfeeding training with LSM was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period, and standard training-video training under the hospital protocol (video training group, n = 64) was provided to pregnant women in the control group. Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels regarding breastfeeding were evaluated in the postnatal period. The data of the research were collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding Attitude and Knowledge Questionnaire, Breastfeeding Self efficacy Scale and Postnatal Period Follow-up Questionnaire. In addition, LSM was employed in the implementation for the simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

32-36 between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.

Related Conditions & MeSH terms

• Breastfeeding
• Education

Intervention

Other:
• simulation training group
In this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period

Locations

Country	Name	City	State
Turkey	Hamide Arslan Tarus	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LATCH Breastfeeding Diagnostic and Assessment Scale	LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding. Cronbach's alpha value was found to be 0.95 in the study in which the Turkish validity and reliability of the scale was carried out.	The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.
Secondary	Breastfeeding Attitude and Knowledge Questionnaire	This form was created by researchers in line with the literature in order to determine the attitudes and knowledge levels of pregnant women towards breastfeeding.In the form, there are a total of 20 statements, 10 statements questioning the level of knowledge about breastfeeding and 10 statements questioning the attitude towards breastfeeding. Each statement in the form is marked as "True", "Wrong", "I don't know" according to the attitude and knowledge level of the people. In the evaluation of the form, correct answers were given as "1", "I don't know" or wrong answers were given "0" points. The lowest score that can be obtained from the entire form is 0 and the highest score is 20. The Cronbach's alpha value of the attitude and knowledge evaluation form regarding breastfeeding was found to be 0.60 in the antenatal period and 0.75 in the postnatal period. A high score on the form indicates a high level of positive attitude and knowledge about breastfeeding.	It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Secondary	Breastfeeding Self-Efficacy Scale-Short Form	Breastfeeding Self-Efficacy Scale consists of 14 items. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods. The difference of the antenatal form of the scale from the postnatal form is that the phrase "future tense" is used in the scale items. In the original study of the scale, the Cronbach's alpha value of the antenatal form was 0.87, and the Cronbach's alpha value of the postnatal form was 0.86.	It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.